The following data is part of a premarket notification filed by Litecure, Llc with the FDA for Lc Therapy, Model Lct-1000.
| Device ID | K070400 |
| 510k Number | K070400 |
| Device Name: | LC THERAPY, MODEL LCT-1000 |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | LITECURE, LLC 930 OLD HARMONY ROAD SUITE A Newark, DE 19713 |
| Contact | Brian Pryor, Ph.d. |
| Correspondent | Neil E Devine Jr INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-02-12 |
| Decision Date | 2007-02-28 |
| Summary: | summary |